FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
X-PAK
K Number: K791917
·
Decision Oct 30, 1979
Classifications
1
FEI Numbers
234
Registration Numbers
235
Same Product Code
76
Applicant Total
3
Review Days
35
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Basic Information
- Device Name
- X-PAK
- K Number
- K791917
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Contemporary Surgical Systems, Inc.
- Date Received
- September 25, 1979
- Decision Date
- October 30, 1979
- Product Code
- HMX
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HMX | Cannula, Ophthalmic | FDA class 1 | Ophthalmic |
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